Systems and methods for design and 3-d fabrication of laryngoscopes, pharyngoscopes, and oral cavity retractors

ABSTRACT

In one aspect, a method of redesigning a laryngoscope, a pharyngoscope, or an oral cavity retractor is disclosed, which includes generating a computerized 3-D model of a laryngoscope, pharyngoscope, or an oral cavity retractor, adjusting one or more parameters of the 3-D model to obtain a 3-D design of a laryngoscope, pharyngoscope, or oral cavity retractor that can provide a desired visual access to the upper aerodigestive tract of a patient or a group of patients, and fabricating a laryngoscope, pharyngoscope, or an oral cavity retractor based on said 3-D design using an additive manufacturing technique, such as 3-D printing.

RELATED APPLICATIONS

The present patent application claims priority to Provisional PatentApplication No. 63/251,600 filed on Oct. 21, 2021, which is hereinincorporated by reference in its entirety.

TECHNICAL FIELD

The following disclosure relates to systems and methods for designingand fabricating unique laryngoscopes, pharyngoscopes, and oral-cavityretractors and more particularly to such systems and methods that allowdesigning and fabricating individualized laryngoscopes, pharyngoscopes,and oral cavity retractors.

BACKGROUND

Examination of the larynx, pharynx, and oral cavity are done with variedforms of retractors, spatulas, and speculums. Since the larynx andpharynx are deeper in the upper aerodigestive tract than the oralcavity, the instruments to visualize and/or treat these anatomicalregions are often referred to as laryngoscopes and pharyngoscopes.Consequently, laryngoscopy and pharyngoscopy are procedures in which aphysician examines a patient's larynx or pharynx to provide access tothe anatomical regions of interest. For example, a laryngoscope providesa surgeon with access to examine and perform surgery on the glottis(true vocal cords), supraglottis (epiglottis, aryepiglottic folds, andfalse vocal cords), and subglottis (cricoid region). Moreover, becauseof the complex disparate anatomy of the different anatomical subsites ofthe larynx and pharynx, a physician might employ a glottiscope,subglottiscope, supraglottiscope, or differing pharynx specula. Duringendoscopic minimally-invasive surgical procedures, the surgeon must haveoptimal visual access to the problematic area to perform preciseoperations. For example, a glottiscope should be designed to provide thegreatest access possible to the vocal cords. Unfortunately, due toextreme anatomical variations between patients, a laryngoscope orpharyngoscope used on one patient may not provide optimal visual accessto the desired anatomical structure when used on another patient. Inaddition, similar to many craftsmen who prefer select tools, surgeonsoften develop an affinity for selected laryngoscopes and pharyngoscopesdue to prior training, ongoing familiarity, and habitual style ratherthan optimal functionality. These surgeons often prefer disparateattributes of different scopes, however, often they must choose aprimary design preference and unavoidably forego secondary preferences.

SUMMARY

Aspects of the present disclosure address the above-referenced problemsand/or others.

The present teachings generally provide methods and systems fordesigning and fabricating laryngoscopes, pharyngoscopes, and oral cavityretractors (herein collectively referred to individually as “a transoralinstrument” or simply “an instrument” and in plural as “transoralinstruments” or “instruments”). In some embodiments, the methods andsystems disclosed herein can be utilized to redesign one or morecomponents/segments of existing instruments to enhance theirfunctionality while retaining advantageous attributes of othercomponents/segments thereof. By way of example, the redesignedinstruments can be fabricated using 3-D printing techniques, asdiscussed in more detail below.

By way of example, and as discussed in more detail below, computermodeling systems, such as Computer Aided Design tools, can be employedin accordance with the present teachings to design a laryngoscope, apharyngoscope, or an oral cavity retractor, or redesign one or morecomponents/segments of an existing laryngoscope, pharyngoscope or anoral cavity retractor so as to maximize the exposure of the upperaerodigestive tract cavities when used by a surgeon.

As discussed in more detail below, the methods for designing orredesigning according to the present teachings can be used to design andfabricate laryngoscopes, pharyngoscopes, and/or oral cavity retractorsthat can provide optimal visual access to a target anatomic site, (e.g.,upper aerodigestive tract cavities), for an individual patient or agroup of patients, (e.g., based on common anatomical features). In someembodiments, a three-dimensional model of the upper aerodigestiveanatomy of a patient or a group of patients (herein also referred to asan anatomical profile) can be created using imaging data. In general,the anatomical features that can affect access to the aerodigestivetract can be used in the three-dimensional model. By way of example, andwithout limitation, such anatomical features can include, for example,three-dimensional contours of the airway lumen based on bone structures,e.g., jaw bones, teeth, cervical spine, as well as associatedsoft-tissue. Further, the rheology of soft tissues of the aerodigestivetract, such as the tongue, palate, and/or pharynx musculature, can alsobe employed in modeling the anatomical profile of the aerodigestivetract. For example, certain groups of individuals may have diminishedtissue distensibility/pliability due to, radiation treatment and/ortrauma, which can render it difficult to gain access to theiraerodigestive cavities. By way of further example, the anatomicalprofile may include the three-dimensional profile of a patient's (or agroup of patients') jaw-opening capacity, the size (e.g., the diameter)of the aerodigestive lumen, the anatomical soft-tissue structuralconformation as well as the geometrical relationships between suchanatomical structures.

In some embodiments, the instruments can be designed, or redesigned, inaccordance with the present teachings for a group of patients thatexhibit similar anatomical profiles of their aerodigestive tracts, orcertain features thereof. For example, some patients with Down syndromemay have relative macroglossia narrowing of the oropharyngeal inlet,which can interfere with gaining access to their aerodigestive tract. Byintegrating the 3-D reconstructed imaging from a CT-scan that delineatesshape of the lumen, with the spatial relationships of the anatomicstructures (junction of the glossotonsillar sulcus with the posteriorfloor of mouth) and soft tissue distensibility, the scope speculum canbe suitably tailored and the optimal substrate material can be selected(e.g. titanium or cobalt chrome, etc.)

In other embodiments, the instruments can be designed, or redesigned,for patients who have undergone radiation treatment. As noted above,such patients may have soft tissues with diminished distensibility. Forexample, restricted jaw opening (trismus) along with stiff fibrotictissue from prior radiotherapy will lead to laryngoscope shapes,contours, and narrowing requirements to accommodate these anatomicrestrictions to positioning laryngoscopes, pharyngoscopes, or oralcavity retractors.

In some embodiments, the instruments can be designed, or redesigned, fora group of patients having one or more characteristics in common byobtaining anatomical profiles of a number of patients in that group andgenerating an average anatomical profile, e.g., by averaging variousanatomical parameters, such as those disclosed herein.

In some embodiments, structural finite element analysis (FEA) can beutilized to analyze the response and tolerance of variouscomponents/segments of an instrument to stress and/or strain generatedby a variety of simulated applied forces, such as those to which theinstrument may be subjected during use. By way of example, such analysiscan be used to assess different designs generated in accordance with thepresent teachings. For example, one or more design parameters that canaffect visual access to the upper aerodigestive tracts can be variedover a range and the finite element analysis can be utilized to assessthe response of various components/segments of the instrument to a setof applied forces for the different values of the design parameters. Theanalysis can then be employed to obtain design parameters that result inan instrument that permits optimal visual access to the aerodigestivetract while providing information regarding component(s)/segment(s) ofthe instrument that may require structural strengthening(reinforcement), e.g., by increasing the thickness of thosecomponent(s)/segment(s), without increasing wall thickness that wouldimpede insertion and positioning of the scope. For example, thickenedareas of the scope/speculum manufactured by 3-D printing can depositadditional materials on certain sections of the instrument and/orchanging the material from which those component(s)/segment(s) arefabricated but not limit the instrument's functionality.

Subsequent to designing or redesigning an instrument according to thepresent teachings, e.g., via the use of imaging data and Computer AidedDesign tools, the instrument can be fabricated using a variety ofmanufacturing techniques including, without limitation, additivemanufacturing techniques, such as 3-D printing, CNC (computer numericalcontrol) machining and/or selective laser sintering. It has beendiscovered that 3-D printing methods can be particularly advantageousfor fabricating instruments designed in accordance with the presentteachings. For example, 3-D printing techniques can be advantageouslyutilized for facile modification of certain structuralcomponents/segments of an instrument so as to provide structuralreinforcement of those component(s)/segment(s). For example, 3-Dprinting can be used to deposit additional material on certain portionsof the instrument to strengthen those portions, e.g., a region inproximity of a handle attachment element and a top plate of theinstrument (speculum), as discussed in more detail below.

In some embodiments, the present teachings can be utilized to analyzeexisting laryngoscopes, pharyngoscopes, and/or oral cavity retractors toidentify those features that attribute to optimal functioning of theinstrument as well as those features, if any, that are sub-optimal. Thepresent teachings can then be utilized to redesign the instrument so asto retain the optimal features while modifying the sub-optimal featuresto create new instruments based, for example, on individuals' anatomy,surgeon preference, and varying holding device or suspension gallows.

In one aspect, a method of redesigning a laryngoscope, a pharyngoscope,or an oral cavity retractor is disclosed, which includes generating acomputerized 3-D model of a laryngoscope, a pharyngoscope, or an oralcavity retractor, adjusting one or more parameters of the 3-D model soas to obtain a 3-D design of the laryngoscope, the pharyngoscope or theoral cavity retractor that can provide a desired visual access to theupper aerodigestive tract of a patient or a group of patients, andfabricating a laryngoscope, a pharyngoscope or an oral cavity retractorbased on said 3-D design using an additive manufacturing technique, suchas 3-D printing. In some embodiments, certain structural features of theinstrument that is being redesigned are retained while other featuresare modified (redesigned) so as to enhance the instrument'sfunctionality, e.g., providing better visual access to a surgical site.

In some embodiments, the redesign of the instrument can be informed by3-D modeling of the anatomy of the aerodigestive tract, including bonestructures and soft tissues. In some embodiments, an anatomical profileof the aerodigestive tract of a patient or a group of patients can beacquired, and the computerized 3-D model can be generated based on thatanatomical profile.

In some embodiments, a structural finite element analysis can beutilized to identify one or more segments or components associated witha 3-D design, generated as indicated above, that require structuralstrengthening/reinforcement. In such cases, the fabrication of thelaryngoscope, the pharyngoscope, and/or the oral cavity retractor caninclude structurally configuring the identified one or more segmentsand/or components so as to provide structural reinforcement of thosesegments(s) and/or component(s). By way of example, those identifiedcomponent(s)/segment(s) can be fabricated with a thickness, shape and/orcomposition such that those segment(s) and/or component(s) can withstandforces applied thereto during use.

In some embodiments, the present teachings relate to methods and systemsfor designing and fabricating a laryngoscope that includes a speculumhaving a base plate (herein also referred to as the bottom portion) anda top plate (herein also referred to as the top portion) that is coupledto the base plate to form a tubular speculum. In some cases, thestructural strengthening of such a speculum can include adjusting thethickness, shape, and/or composition of a wall of the speculum or aportion thereof. By way of example, and without limitation, a portion ofthe upper plate in the proximity of a handle attachment element of thelaryngoscope can be structurally reinforced to ensure that the speculumcan withstand forces to which the junction of the handle attachmentelement and the top plate are exposed during use. By way of example, andwithout limitation, in some cases, the thickness of such portions can beincreased relative to the other portions of the top plate by a factor ina range of about 10% to 100%, e.g., in a range of about 20% to about80%, or in a range of about 30% to about 70%. Instead, or in addition,those portions can be made of a different material, e.g., a differentmetal, that can provide a more robust structural integrity. Further, theshape, e.g., the curvature, of those portions can be modified, e.g., thecurvature can be reduced or increased, to render those portions lesssusceptible to structural failure when the laryngoscope is in use.

In one aspect, a method of producing a laryngoscope, a pharyngoscope, oran oral cavity retractor includes generating an anatomical profile of apatient, or an average anatomical profile associated with a patientgroup, and producing one or more components of a laryngoscope,pharyngoscope, or oral cavity retractor based on the anatomical profile.In some embodiments, the method further includes imaging of patients'upper aerodigestive tract, e.g., utilizing a variety of imagingtechniques known in the art such as those disclosed herein, therebygenerating image data and integrating the image data into the anatomicalprofile. The anatomical profile may include the three-dimensionalprofile of the patients' jaw-opening capacity, aerodigestive lumen, andanatomical soft-tissue structural conformation as well as a rheologicalassessment of the anatomic soft tissues peripheral to the airway lumen.The method may further include producing the component(s) of thelaryngoscope, pharyngoscope, and/or oral cavity retractors with additivemanufacturing techniques, such as three-dimensional (3D) printing. Thecomponents may comprise a metal, plastic, or composite material. In someembodiments, the method further includes determining one or morematerials from which one or more components of the laryngoscope, thepharyngoscope, and/or the oral-cavity retractor may be fabricated basedon at least one of the anatomical profile, structural requirements, easeof maintenance and sterilization, and economy of production. Thecomponent may be a top plate of a speculum or a base plate thereof. Insome embodiments, the method further includes determining a parameter ofthe component based on the anatomical profile and producing thecomponent based on the determined parameter. By way of example, theparameter may include the length of any of the speculum components(i.e., the longitudinal distance between the proximal and the distalends of these components), the inner diameter of the lumen of thespeculum, the radius of curvature of the speculum, a tilt angle of aproximal portion of the base plate relative to the rest of thebaseplate, among others. Additionally, these geometric parameters andrelationships can be suitably altered to accommodate a wide range ofanatomic variations based on age, gender, prior injury, prior medicaltreatment such as radiotherapy, and a range of other comorbid factors.

In another aspect, a method for reconfiguring a laryngoscope, apharyngoscope, or an oral cavity retractor is disclosed, which includesgenerating a 3-dimensional profile of the laryngoscope, thepharyngoscope, or the oral cavity retractor and using the 3-dimensionalprofile to generate a modified design of at least one or moresegment(s)/component(s) of the laryngoscope, the pharyngoscope, or theoral cavity retractor, e.g., utilizing Computer Aided Design tools. Byway of example, such a modified design may maintain the profile of thedistal end of the instrument, but change one or more parameters of theinstrument's proximal end, e.g., to improve visual access to a targetsite, especially if used with a surgical microscope. Altering theproximal portion of the laryngoscope may also be done to enhance theability of an assistant to pass microscopic instruments to the surgeonby providing wider access to the lumen of the laryngoscope withoutobstructing the view of the microsurgical field of view. By way ofanother example, the modified design can relate to structurallyreinforcing one or more segments of the instrument. Such structuralreinforcement can be achieved, for example, by using a differentmaterial for the fabrication of that segment or increasing the thicknessof that segment. In some embodiments, the modified design can beimplemented using 3-dimensional (3-D) printing.

In other words, in embodiments, 3-D profiling of an existing instrumenttogether with the use of Computer Aided Design for redesigning one ormore portions of the instrument to generate a modified design, whichcan, for example, retain the profile and function of certain portions ofthe instrument while modifying other portions, and utilizing 3-Dprinting to implement the modified design can be used to fabricate anenhanced version of existing instruments.

In some embodiments, the redesign of an existing instrument according tothe present teachings results in a modified instrument that can retainthe primary structural and functional attributes of certain portionsthereof while enhancing the structural and functional attributes ofother portions.

The use of 3-D printing techniques, integrated with CAD tools, for theredesign of existing scopes, which are used, for example, in humanendoscopic upper aerodigestive tract surgery, can provide certainadvantages. By way of example, computerized analysis of structuralstress and strain in various regions of an existing instrument can beutilized to identify regions of the instrument that are subjected tosignificant retraction forces. The thickness of such regions can bevaried using, e.g., composite 3-D printing materials. Another advantageof the present teachings, and in particular using 3-D printing forfabricating oral instruments, is the ability to fabricate instruments ondemand so that production of large quantities and maintenance ofinventory can be fluidly scaled. In embodiments, the present teachingscan facilitate the rapid and efficient design and/or redesign oftransoral instruments and their fabrication using, e.g., additivetechniques such as 3-D printing techniques.

In another aspect, a system for designing and fabricating laryngoscopes,pharyngoscopes, and oral cavity retractors includes acomponent-producing system, a computer-readable storage medium withcomputer readable program instructions, and a processor in communicationwith the computer-readable storage medium, wherein the processor isconfigured to execute computer readable program instructions stored inthe computer-readable storage medium that can cause the processor todetermine an anatomical profile of a patient, and in particular theanatomical profile of the patient's larynx, oropharynx, and oral cavityand send a signal to a component-producing system to produce thecomponent based on the anatomical profile. In some embodiments, theprocessor is further configured to determine parameters of a componentof a laryngoscope, a pharyngoscope, or an oral-cavity retractor based onthe anatomical profile and in response to receiving the signal, and thecomponent-producing system is further configured to produce thecomponent based on the parameters. The parameters may include, e.g., thelength of a laryngoscope component, such as the length of any of thecomponents of the speculum, such as the top plate and/or the base plate,the inner diameter of the lumen of the speculum, the radius of curvatureof the speculum, a tilt angle of a proximal portion of the base platerelative to the rest of the baseplate. In some embodiments, theconfigured processor is further configured to determine one or moredesign parameters of the instrument based on image data acquired for anindividual patient or a group of patients. The component-producingsystem may be a 3D printer or other additive manufacturing equipment.The component may be a speculum, including a base plate and a top plateof a speculum. The material of the component may be metal, plastic, or acomposite. In some embodiments, the configured processor is furtherconfigured to determine the material based on the anatomical profile,e.g., rheological information about the deformability of anatomic softtissue of interest and/or other tissue. Although in many embodimentscurrent stress/strain tolerance requires the use of a metal for forminga transoral instrument according to the present teachings, needstypically require metal, future constituent materials may have enoughstrength and be easier to print. Additionally, in embodiments of thepresent teachings, the use of stress/strain pressure profile of theinstrument will enable more precise metal selection (e.g., titaniumversus cobalt chrome) for fabrication of various components of aninstrument, e.g., scope-speculum, as well as the selection of one ormore geometrical parameters of those components, e.g., the thickness ofthe components.

In some embodiments, a three-dimensional reconstruction of the bone,cartilage, soft tissue, and aerodigestive lumen can be extracted fromcomputerized axial tomography (CAT-Scan). These data can be integratedwith structural features of soft tissues of the oral cavity, pharynx,and larynx, which can be critical for designing laryngoscopes,pharyngoscopes, and oral cavity retractors. Abnormal structural featuresof soft tissues are often manifested as local stiffening. Elastic andmechanical properties of soft tissues can be measured in vivo withenhanced spatial resolution using techniques such as micro-indentation,microelectromechanical (MEMS) based cantilever sensors, and opticalcatheters.

In yet another aspect, a method according to the present teachingsincludes analyzing one or more components of an existing laryngoscope,pharyngoscope, or oral-cavity retractor to determine one or moreparameters of the component(s), herein also referred to as one or moreactual parameters, determining one optimal parameter for at least one ofthe one or more component(s) of the instrument based on an anatomicalprofile, comparing the actual parameter of the component with theoptimal parameter of the component to determine if the actual parameteris the same as the optimal parameter, and in response to determining theactual parameter is not the same as the optimal parameter, producing thecomponent with the optimal parameter.

In yet another aspect, a method of fabricating a laryngoscope, apharyngoscope, or an oral-cavity retractor having a speculum for usewith an individual patient or a group of patients, includes collectinganatomical data regarding an individual patient's larynx, pharynx and/ororal cavity and obtaining one or more structural and/or compositionalparameters of at least one of the components of such an instrument,e.g., the speculum or a component thereof (e.g., a base plate or a topplate of the speculum), by adjusting the parameters so as to obtain adesired visual access to a site of interest when using the instrument tovisualize that site in the patient, and using the parameters tofabricate the component(s), e.g., the speculum or a component thereof(such as a base plate or a top plate). In some embodiments the step ofobtaining said one or more structural and/or compositional parametersincludes generating a computerized model of the laryngoscope,pharyngoscope, or oral-cavity retractor. In some embodiments, the methodfurther includes using the computerized model to adjust the one or morestructural and/or compositional parameters.

In a related aspect, a method of redesigning a laryngoscope, apharyngoscope, or an oral cavity retractor is disclosed, which includesgenerating a computerized 3-D model of a laryngoscope, pharyngoscope, oran oral cavity retractor, adjusting one or more parameters of the 3-Dmodel to obtain a 3-D design of a laryngoscope, a pharyngoscope, or anoral cavity retractor that can provide a desired visual access to theupper aerodigestive tract of a patient or a group of patients, andfabricating a laryngoscope, a pharyngoscope, or an oral cavity retractorbased on said 3-D design using an additive manufacturing technique, suchas 3-D printing.

In some embodiments, the method can further include acquiring anatomicalprofile of a patient or a group of patients and generating saidcomputerized 3-D design of the laryngoscope, pharyngoscope or the oralcavity retractor based on said anatomical profile.

In some embodiments, a structural finite element analysis can beemployed to identify one or more segments or components associated withsaid 3-D design that require structural reinforcement. The fabricationstep can then include structurally configuring the identified segment(s)or component(s) so as to provide structural reinforcement thereof. Byway of example, the structural reinforcement of the identifiedsegment(s) or component(s) can include adjusting any of a thickness,shape and/or composition of those segment(s) or component(s). Thestructural reinforcement can be designed such that the structurallyreinforced segment(s) or component(s) can withstand the forces appliedthereto when the instrument is used by a surgeon.

In some embodiments, the instrument can include a speculum having a topplate coupled to a base plate and the method includes adjusting at leastone of a thickness, shape and composition of at least a portion of thetop plate to provide structural reinforcement of that portion.

In some embodiments, the desired visual access can be characterized by amaximum tilt of a surgical microscope that is optically coupled to theinstrument relative to a longitudinal axis of the instrument that can beused for viewing a surgical site of interest in the aerodigestive tractof a patient or a group of patients. For example, such a maximum tiltcan be about 20 degrees, or about 30 degrees, or about 40 degrees.

Further understanding of various aspects of the present teachings can beobtained by reference to the following detailed description inconjunction with the associated drawings, which are described brieflybelow.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure may take form in various componentsand arrangements of components, and in various steps and arrangements ofsteps. The drawings are only for illustration purpose of preferredembodiments of the present disclosure and are not to be considered aslimiting.

Features of embodiments of the present disclosure will be more readilyunderstood from the following detailed description taken in conjunctionwith the accompanying drawings in which:

FIG. 1 illustrates a laryngoscope in accordance with an exemplaryembodiment of the present disclosure;

FIG. 2 diagrammatically depicts a computer system in accordance with anexemplary embodiment;

FIG. 3 diagrammatically depicts a cloud computing environment inaccordance with an exemplary embodiment;

FIG. 4 is a flow chart of a method for producing a laryngoscope inaccordance with an exemplary embodiment;

FIG. 5 is a flow chart of a method for analyzing geometric parameters ofa laryngoscope in accordance with an exemplary embodiment;

FIG. 6A schematically depicts a speculum of a conventional laryngoscope;

FIGS. 6B and 6C are schematic proximal and distal views of the speculumdepicted in FIG. 6A, respectively;

FIGS. 7A and 7B provide examples of calculated pressures, computed usingfinite element analysis, that are expected to be applied to theconventional speculum of FIG. 6A when used by a surgeon to provideaccess to a surgical site in the aerodigestive tract;

FIG. 8A is a schematic view of a speculum of a laryngoscope according toan embodiment of the present teachings;

FIGS. 8B, 8C, 8D, and 8E are, respectively, the proximal view, thedistal view angled up, the distal view angled down, and the distal viewangled down (with additional tilt relative to FIG. 8D), of the speculumof FIG. 8A;

FIGS. 9A and 9B are top views of the base plate of the speculum depictedin FIG. 8A, depicting a curved bottom surface of the base plate;

FIG. 9C is a schematic view of the proximal portion of the speculumdepicted in FIG. 8A;

FIG. 9D shows the results of finite element analysis of pressuresexperienced by the proximal portion of the speculum depicted in FIG. 9C;

FIG. 10A is a side schematic view of a speculum that incorporatesfeatures of a conventional speculum as well as several featuresdisclosed herein;

FIG. 10B is a partial perspective view of a proximal portion of thespeculum depicted in FIG. 10A,

FIG. 10C is a proximal axial view of the speculum depicted in FIG. 10A;

FIG. 10D shows the results of finite element analysis of pressuresexpected to be experienced by the proximal portion of the speculumdepicted in FIG. 10A, and;

FIGS. 11A and 11B schematically depict two different orientations of asurgical microscope with a front lens that is used to view the larynxthrough a laryngoscope speculum.

DETAILED DESCRIPTION

In some aspects, the present disclosure generally relates to a systemand method for designing or redesigning and fabricating laryngoscopes,pharyngoscopes and oral-cavity retractors. A variety of theseinstruments have been used for over two centuries to examine and performprocedures on the oral cavity and throat. For example, a patient mayundergo phonomicrosurgery to improve or maintain their voices. Variousvocal-fold anomalies (e.g., polyps, nodules, cysts, granulomas,papilloma, epithelial dysplasia, cancerous growths, etc.) may cause thevoice to become distorted. During phonomicrosurgery, a surgicalmicroscope is used to view the anomalies. As such, this operation may beoptimized by obtaining the widest glottal surgical field to exposevocal-fold anomalies. A laryngoscope with an internal lumen may be usedto view a pathology or an anomaly during phonomicrosurgery. The purposeof a laryngoscope (as well as other instruments used during medicalprocedures involving the throat) is to provide the widest viewing andoperating area as possible to the surgeon. Unfortunately, a universallyshaped laryngoscope may not provide the widest viewing and operatingarea possible to all patients due to anatomical variations, such as thejaw-opening capacity, size and/or shape of the mouth and throat, tissuedistensibility (rheometry) diminishment from radiation or trauma amongdifferent individuals. Further, conventional laryngoscopes may notprovide optimal visual access to a surgical site.

In some aspects, the present disclosure provides a system and method fordesigning or redesigning and producing a laryngoscope, a pharyngoscope,and an oral-cavity retractor, that is specifically tailored to apatient's anatomy or an average anatomy of a group of patients.Providing a system and method for producing such an instrument that isindividualized to a patient's or a group of patients' anatomy mayprovide the widest viewing and operating area as possible by exposingregions of the larynx, oropharynx, and oral cavity, for example,irrespective of age, gender, deformities, or prior surgery. In thefollowing discussion, various aspects of the present teachings aredescribed primarily in the context of designing or redesigning andfabricating laryngoscopes, but it should be understood that the presentteachings can be applied to pharyngoscopes and oral-cavity retractors.

In some aspects, the present disclosure relates to modifying alaryngoscope, pharyngoscope, or oral cavity retractor to improve itsfunctionality. By way of example, a CAD tool can be utilized to redesignone or more components/segments of such an instrument and 3-D printingcan be used to fabricate the redesigned instrument. For example, theredesign of the instrument can improve its functionality, e.g., byproviding an enhanced field of view of the aerodigestive tracts to asurgeon, and/or strengthen certain components/segments of the instrumentthat experience significant stress/strain when used to view a patient'slarynx, pharynx or oral cavity.

As used herein, the term “about” means plus or minus 25% of a numericalvalue. Therefore, about 200 μm means in the range of 75-125 μm.

As discussed in more detail below, in various embodiments, imagingtechniques, such as diagnostic endoscopy (flexible and rigid) as well asvarying forms of imaging such as computerized axial tomography, magneticresonance imaging and/or rheometric measurements of head and neck softtissues and/or jaw-opening capacity can be employed to provide a profileof the throat, and the profile can be utilized to fabricate an optimallaryngoscope for, e.g., for an individual patient or a group ofpatients, e.g., a laryngoscope that can provide a maximum visual accessto the anatomical tissue of interest for an individual patient or agroup of patients. For example, such imaging information from differentimaging modalities can be integrated to obtain a specific anatomicprofile that can be utilized to design and fabricate a speculum of alaryngoscope or a pharyngoscope that optimally exposes regions of thelarynx, oropharynx, and oral cavity irrespective of age, gender,deformities, or prior surgery, etc.

For example, as discussed in more detail below, the anatomicalinformation can be used to optimize the geometry of the speculum (FIG. 1) of the laryngoscope, e.g., via adjusting different geometricalparameters of the base plate and or top plate of the speculum anddetermining the degree of visual access for each set of geometricalparameters so as to arrive at optimal values of those parameters. Forexample, in some cases, computerized design software can be used formodeling and adjusting various geometrical parameters of thelaryngoscope. In some embodiments, an expert medical professional maydetermine the degree of exposure provided by each set of the geometricalparameters until an optimized set is achieved. In other embodiments, acomputerized system can define and optimize a figure-of-merit indicativeof the degree of exposure of an anatomical tissue of interest for agiven set of the geometrical parameters of the laryngoscope and arriveat an optimal set of parameters based on optimizing (e.g., maximizing)that figure-of-merit. By way of example, and without limitation, in someembodiments, the figure-of-merit can be defined as a maximum tilt of asurgical microscope that is optically coupled to the instrument relativeto a longitudinal axis of the instrument that can be used for viewing asurgical site of interest in the aerodigestive tract of a patient or agroup of patients. Other figures-of-merit can also be defined andemployed in the practice of the present teachings.

In some embodiments, the optimized geometry output obtained for thelaryngoscope can then be integrated into a computer-aided design programand used with an additive manufacturing method, such asthree-dimensional printing, to create a tailored speculum/device that ishighly customized to allow for optimal exposure of the desiredanatomical region.

In some embodiments, the materials for fabricating the speculum of thelaryngoscope can be selected (metals, plastics, composites) based on theshape, contour, size, ergonomics, anatomical stiffness (e.g., postradiation treatment) and other requirements so as to produce an optimalspeculum (instrument), for example, for a custom-tailored instrument fora particular individual or a group of patients. For example, when apatient's anatomical tissue of interest is stiffer and less distensiblethan normal tissue, e.g., due to previous exposure to radiation, e.g.,for treatment of cancerous lesions, rigid metal materials are used forthe fabrication of the speculum, such as its base plate and/or topplate, due to the lack of distensibility of the soft tissues. Someexamples of materials that can be used for the fabrication of thespeculum include without limitation, titanium, stainless steel,cobalt-chrome, aluminum, and polymeric materials employed in 3-Dprinting applications.

A large number of laryngoscopes have been designed over the last 120years to accommodate the variety of human anatomical characteristics,thereby producing many incremental design changes for Otolaryngologists(throat surgeons), anesthesiologists, oral surgeons and dentists.However, the majority of these designs have been dedicated totranslaryngeal orotracheal intubation for the administration of generalanesthesia. The viewing exposure required for this task is primarilylimited to viewing the interarytenoid region of the glottal introitusfor passage of an endotracheal tube into the trachea to administergeneral anesthesia. The design of laryngoscopes, pharyngoscopes, andoral cavity retractors typically present more challenges assignificantly wider viewing field is required for performing surgery.Anatomical regions such as but not limited to the anterior glottalcommissure of the larynx and the pyriform sinus of the laryngopharynxare mechanically more difficult to expose. Performing surgery on theseanatomical regions is made even more difficult by the frequent use of amagnifying surgical microscope with binocular objectives and a frontlens. The optics of the converging images of a surgical microscoperequire a wider proximal lumen for a laryngoscope or pharyngoscopefurther complicating the requirements of the proximal size and shape ofan endoscopic speculum. When feasible, maintaining the use of thesurgical microscope is advantageous since it provides the operator withstereoscopic viewing and depth perception along with delicate bimanualtactile proprioception of soft tissue during magnified tissuedissection. These precise microsurgical advantages are not availablewhen employing surgical technologies that rely on flexible or curvingendoscopes that provide a view that requires the surgeon to use one eyeor a screen to use both eyes. Viewing technologies of the larynx thatare associated with simpler manual tasks (e.g., orotracheal intubation)can be achieved without a surgical microscope. However, highly delicatebimanual surgery optimized by proprioception (e.g., larynx, eye, brain)are best suited for a surgical microscope. Unlike the eye or brain, thelarynx and pharynx require complex endoscopic speculum to provide theexposure and instruments are fewer in number. Moreover, the designrequirements for optimal exposure of a surgical operative site withinthe upper aerodigestive tract cavity (e.g., to remove a tumor), alongwith the forces required to displace soft tissue for that exposure,compound the economic manufacturing feasibility of optimalinstrumentation that can achieve these mandates. Consequently, themethods of fabricating laryngoscopes as disclosed herein allow forgroups of similar patients or even an individual patient to have acustom-tailored laryngoscope/pharyngoscope that can be employed fordiagnostic and/or therapeutic procedures performed on that patient.

In another aspect of the present teachings, the methods disclosed hereincan also be employed to analyze previously-fabricated laryngoscopes, orother transoral instruments (e.g., those fabricated based onconventional methods, e.g., via economically sound production (tooling)techniques) to identify those features that are optimal for use, e.g.,with an individual subject (e.g., patient) or a group of individuals (oras a universal laryngoscope) and also identify those features that arenot optimal (e.g., those features that negatively impact thelaryngoscope's function). Such analysis and efficient redesign andproduction of modified versions of existing laryngoscopes andpharyngoscopes by applying extremely nuanced detailed modificationsthereto provide instruments with enhanced functionality for thephysician and surgeon. By way of example, such an improved laryngoscopecan be fabricated via making physical changes to an existinglaryngoscope. By way of example, the structural strength of certaincomponents/segments of an existing laryngoscope/pharyngoscope and/orcertain geometrical parameters of the laryngoscope/pharyngoscope (e.g.,the size of lateral slots) may be sub-optimal. As another example, suchgeometrical parameters may limit the delivery of light guides and/orsuction cannula into the instrument. However, fabricating a newlaryngoscope (e.g., using 3-D printing techniques) based on the enhanceddesign parameters, can precisely remove/modify the negativecharacteristics of the previously-fabricated laryngoscope byconventional tooling methods while retaining their positivecharacteristics.

Consequently, in some embodiments, the spectrum of specula/instrumentsthat exist can be modified for enhanced function and three-dimensionallyprinted.

Referring now to FIG. 1 , a laryngoscope 100 is shown in accordance withan exemplary embodiment, which can be designed and fabricated using thepresent teachings. The laryngoscope 100 may be modular. That is, eachcomponent of the laryngoscope 100 may be individually produced (e.g., bya three-dimensional (3D) printer or by another additive manufacturingsystem).

The laryngoscope 100 includes a speculum 102 having a baseplate 104 thatis removably coupled to a top plate 103. Although in this embodiment thetop plate 103 and the baseplate 104 are removably coupled to oneanother, in other embodiments, they can form an integral unit. As willbe discussed in further detail herein, the speculum 102 may be made of atissue-compatible material (e.g., capable of withstanding an acidicenvironment of a tissue) including, but not limited to metals, plastics,and composite materials and may be produced by a 3D printer. In someembodiments, the laryngoscope and/or pharyngoscope may have componentsof different materials. For example, top plate (i.e., an upper portion)of the speculum may be made of a metal to withstand retraction forcesbut the baseplate, and cannulas for suction and lighting may be made ofplastics that are disposable since these parts are more difficult toclean and sterilize. The choice of the materials may also be based oninformation in an anatomical profile of the throat of an individualpatient or a group of patients. For example, an anatomical profile mayinclude information regarding whether the patient had previouslyundergone throat radiation treatment. Generally, after radiationtreatment, a tissue may lose some of its elasticity. In someembodiments, in addition to consideration regarding the elasticity of ananatomical tissue of interest, the ease of fabrication as well as thefabrication cost may inform the choice of materials for use in thefabrication of a laryngoscope.

The top plate 103 and the base plate 104 of the speculum 102 extend froma proximal end 106 to a distal end 108 of the laryngoscope 100. The topplate 103 includes a speculum wall 110 and a handle attachment element112. The handle attachment element is configured to attach to an “L”shaped handle (not shown) that allows a surgeon to hold and operate thelaryngoscope 100, e.g., in a manner known in the art.

Referring now to FIG. 2 , a computer system 200 is shown in accordancewith an exemplary embodiment. As used herein a computer system (ordevice) is any system/device capable of receiving, processing, and/orsending data. Examples of computer systems include, but are not limitedto personal computers, servers, hand-held computing devices, tablets,smart phones, multiprocessor-based systems, mainframe computer systems,and distributed cloud computing environments that include any of theabove systems and the like.

As shown in FIG. 2 , the computer system 200 includes one or moreprocessors or processing units 202, a system memory 204, and a bus 206that couples various components of the computer system 200 including thesystem memory 204 to the processor 202.

The system memory 204 includes a computer-readable storage medium 208and volatile memory 210 (e.g., Random Access Memory, cache, etc.). Asused herein, a computer-readable storage medium includes any media thatis capable of storing computer readable program instructions and isaccessible by a computer system. The computer-readable storage medium208 includes non-volatile and non-transitory storage media (e.g., flashmemory, read-only memory (ROM), hard disk drives, etc.). Computerreadable program instructions as described herein include programmodules (e.g., routines, programs, objects, components, logic, datastructures, etc.) that are executable by a processor. Furthermore,computer readable program instructions, when executed by a processor,can direct a computer system (e.g., the computer system 200) to functionin a particular manner such that a computer-readable storage medium(e.g., the computer-readable storage medium 208) comprises an article ofmanufacture. Specifically, the execution of the computer readableprogram instructions stored in the computer-readable storage medium 208by the processor 202 creates means for implementing the functionsspecified in the method 400 depicted in FIG. 4 and the method 500depicted in FIG. 5 .

The bus 206 may be one or more of any 200 of bus structure capable oftransmitting data between components of the computer system 200 (e.g., amemory bus, a memory controller, a peripheral bus, an acceleratedgraphics port, etc.).

In some embodiments, as depicted in FIG. 2 , the computer system 200 mayinclude one or more external devices 212 and a display 214. As usedherein, an external device includes any device that allows a user tointeract with a computer system (e.g., mouse, keyboard, touch screen,etc.). An external device 212 and the display 214 can be incommunication with the processor 202 and the system memory 204 via anInput/Output (I/O) interface 216.

The display 214 may display a graphical user interface (GUI) that mayinclude a plurality of selectable icons and/or editable fields. A usermay use an external device 212 (e.g., a mouse) to select one or moreicons and/or edit one or more editable fields. Selecting an icon and/orediting a field may cause the processor 202 to execute computer readableprogram instructions stored in the computer readable storage medium 208.In one example, a user may use an external device 212 to interact withthe computer system 200 and cause the processor 202 to execute computerreadable program instructions relating to the method 400 depicted inFIG. 4 and the method 500 depicted in FIG. 5 .

The computer system 200 may further include a network adapter 218 whichallows the computer system 200 to communicate with one or more othercomputer systems/devices via one or more networks (e.g., a local areanetwork (LAN), a wide area network (WAN), a public network (theInternet), etc.).

The computer system 200 may be in wired or wireless communication with amedical imaging system 300. The computer system 200 may be in wirelesscommunication with the medical imaging system 300 when the computersystem 200 and the medical imaging system 300 are connected to a samenetwork. The medical imaging system 300 is configured to generate imagedata of the throat and/or tissues that surround the throat.

In one embodiment, the medical imaging system 300 is an imaging systemcapable of imaging, e.g., using any suitable imaging modality such asX-ray, ultrasound, and/or magnetic resonance imaging, an internalanatomy of throat (e.g., a flexible endoscope, a rigid endoscope, etc.)thereby producing image data. In some embodiments, the display 214 or adisplay of the medical imaging system 300 displays the image data.

In another embodiment, the medical imaging system 300 is a computedtomography (CT) imaging system. In such an embodiment, the medicalimaging system 300 includes radiation source and a radiation detector.The radiation source emits radiation that traverses an examinationregion that includes a patient's head and/or throat. The radiation isattenuated by biological material (e.g., bone, tissue, etc.) within theexamination region. The radiation detector detects the attenuatedradiation and generates a plurality of signals indicative of thedetected radiation. A reconstructor of the medical imaging system 300processes the signals and generates image data based on the processedsignals. In some embodiments, the display 214 or a display of themedical imaging system 300 displays the image data.

In yet another embodiment, the medical imaging system 300 is a magneticresonance imaging (MRI) system. In such an embodiment, the medicalimaging system includes a plurality of magnets, a radiofrequencyemitter, and an electromagnetic energy detector. The magnets produce amagnetic field that traverses an examination region that includes thepatient's head and/or throat. The magnetic field forces protons withinbiological material within the examination region to align with respectto the magnetic field. Then, the radiofrequency emitter emits a radiofrequency that forces the protons to change their alignment with respectto the magnetic field. When the radiofrequency emitter is turned off,the protons realign with respect to the magnetic field and releaseelectromagnetic energy. The electromagnetic energy detector detects thereleased electromagnetic energy and generates signals indicative of thedetected electromagnetic energy. A reconstructor of the medical imagingsystem processes the signals and generates image data based on theprocessed signals. In some embodiments, the display 214 or a display ofthe medical imaging system 300 displays the image data.

As will be discussed in further detail herein, the image data may befurther analyzed by a processor (e.g., the processor 202) to determineone or more anatomical parameters of the patient's throat (e.g., such asthe jaw-opening capacity, size and/or shape of the mouth and throat). Inanother embodiment, the image data may be further analyzed by aprocessor (e.g., the processor 202) to determine rheometric data of thepatient (e.g., tissue distensibility (rheometry) diminishment fromradiation or trauma).

In one embodiment, the imaging system captures rheometric data. Inanother embodiment, a rheometer captures rheometric data.

The computer system 200 may be in wired or wireless communication with athree-dimensional (3D) printer 400. The computer system 200 may be inwireless communication with the 3D printer 400 when the computer system200 and the 3D printer 400 are connected to a same network. The 3Dprinter 400 is configured to generate components of the laryngoscope 100based on an anatomical profile of a patient or a group of patients. Forexample, the 3D printer 400 is configured to generate the top plate 102and/or the base plate 104.

Referring now to FIG. 3 a cloud computing environment 300 connected toone or more user computer systems 302 is depicted in accordance with anexemplary embodiment. The cloud computing environment 300 providesnetwork access to shared computing resources (e.g., storage, memory,applications, virtual machines, etc.) to the one or more user computersystems 302 As depicted in FIG. 3 , the cloud computing environment 300includes one or more interconnected nodes 304. Each node may be acomputer system or device with local processing and storagecapabilities. The nodes 304 may be grouped and in communication with oneanother via one or more networks. This allows the cloud computingenvironment 300 to offer software services to the one or more usercomputer systems 302 and as such, a user computer system 200 does notneed to maintain resources locally.

In one embodiment, a node 304 includes the system memory 204 and assuch, includes the computer readable program instructions for carryingthe method 400 of FIG. 4 and the method 500 depicted in FIG. 5 . In suchan embodiment, a user of a user computer system 200 that is connected tothe cloud computing environment 300 may cause a node 304 to execute thecomputer readable program instructions to carry out the method 400 orthe method 500.

Referring now to FIG. 4 , a method 400 for producing a laryngoscope isshown in accordance with an exemplary embodiment. As previouslydiscussed herein, the steps 402-406 of the method 400 may be stored ascomputer readable program instructions in a computer readable storagemedium (e.g., the computer readable storage medium 208). A processorthat is configured according to an aspect of the present disclosure(hereinafter “a configured processor”) executes the computer readableprogram instructions for the method 400. In one embodiment, theconfigured processor is the processor 202.

At 402, the configured processor produces an anatomical profile for apatient or a group of patients. The anatomical profile contains patientinformation and/or information relating to the neck, head, and/or thejaw of the patient (e.g., anatomical parameters, age, gender, priormedical history, etc.). The anatomical profile may be based on imagedata generated by the medical imaging system 300. For example, themedical imaging system may produce image data of a larynx. Based on theimage data, the configured processor may determine the length of theoropharynx and add the length of the oropharynx to the anatomicalprofile. In another example, the configured processor may determine,based on an electronic medical record of the patient, the patientpreviously underwent throat surgery. In this example, the configuredprocessor adds this information to the anatomical profile. Theanatomical profile may further be based on rheometric measurements ofthe head, neck, and jaw. For example, the configured processor mayintegrate solid restrictions such as cephalometric bony anatomy, withthe size and position of the soft tissues and integrate with thedistensibility of the soft tissue based on rheometric data in anindividual patient's soft tissue (e.g., tongue, palate, pharyngealmusculature, laryngeal musculature) or the soft tissue associated with agroup of patients. In another example, the configured processordetermines a 3D shape, contour, size, caliber, and relational differenceof the airway based on image data (captured by the imaging system)and/or rheometric data.

At 404, the configured processor determines material and/or geometricalparameters of a laryngoscope based on the anatomical profile. Theconfigured processor may determine the parameters in a computerizedmodel of the laryngoscope. The configured processor chooses optimalmaterial and/or optimal geometric parameters that will produce alaryngoscope that will allow for optimal exposure of a desiredanatomical region as the determined material and/or geometric parametersand/or minimize the risk of damage to the patient's throat tissue whenemployed.

At 406, the configured processor sends a signal to produce a componentof a laryngoscope based on the determined material and/or geometricparameters to a laryngoscope component-producing element (e.g., a 3Dprinter). In response to receiving the signal to produce a component ofa laryngoscope, the laryngoscope component producing element producesthe component based on the determined material and/or geometricparameters.

Referring now to FIG. 5 , a method 500 for analyzing geometricparameters of a laryngoscope is shown in accordance with an exemplaryembodiment. As previously discussed herein, the steps 502-512 of themethod 500 may be stored as computer readable program instructions in acomputer readable storage medium (e.g., the computer readable storagemedium 208). A configured processor executes the computer readableprogram instructions for the method 500. In one embodiment, theconfigured processor is the processor 202.

At 502, the configured processor determines an actual geometricparameter and/or actual material of a laryngoscope with or withoutintervention from a user of a computer system with the configuredprocessor. The configured processor determines the geometricparameter(s) of the laryngoscope by analyzing the laryngoscope. Inanother embodiment, a user of a computer system with the configuredprocessor may manually input am actual geometric parameter and/ormaterial and the configured processor determines the actual geometricparameter based on the user input.

At 504, the configured processor produces an anatomical profile of apatient or a group of patients (e.g., characterized as an average ofanatomical parameters associated with a sample of patients in thatgroup) as previously discussed herein with respect to 402.

At 506, the configured processor determines an optimal material and/orgeometric parameters of a laryngoscope based on the anatomical profileas previously discussed herein with respect to 504.

At 508, the configured processor determines if a component of thelaryngoscope needs modification by comparing the determined optimalmaterials and/or geometric parameters to the determined actual geometricparameter(s) and/or determined actual material of the laryngoscope. Theconfigured processor determines a component needs modification when adetermined optimal material and/or geometric parameter and a determinedactual material and/or geometric parameter are different.

At 510, in response to determining no components need modification, theconfigured processor causes a display (e.g., the display 214) to displaya notification indicating no components need modification.

At 512, in response to determining that a component needs modification,the configured processor sends a signal to produce the component basedon the determined optimal material and/or geometric parameters to alaryngoscope component producing element. For example, the designinformation can be uploaded in an appropriate format onto a 3-D printingdevice for fabricating the laryngoscope.

As noted above, in some embodiments, one or more geometrical parametersof a laryngoscope according to the present teachings can be adjustedbased on the derived anatomical profile of a subject or a group ofsubjects to obtain an optimal visual access to an anatomical tissue ofinterest. By way of example and without limitation, some examples ofsuch geometrical parameters include the length of any of the top plateand/or the base plate of the speculum, the inner diameter of the lumenof the speculum, the radius of curvature of the speculum, a tilt angleof a proximal portion of the base plate relative to the rest of thebaseplate, among others. While the above methods 400 and 500 describe amethod for producing or analyzing components of a laryngoscope, theabove methods may be implemented to analyze and/or produce components ofpharyngoscopes and oral-cavity retractors.

As previously discussed, the above may be implemented by way of computerreadable instructions, encoded or embedded on computer readable storagemedium (which excludes transitory medium), which, when executed by aprocessor(s), cause the processor(s) to carry out the methods of thepresent disclosure.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive;embodiments of the present disclosure are not limited to the disclosedembodiments. Other variations to the disclosed embodiments can beunderstood and effected by those skilled in the art in practicingembodiments of the present disclosure, from a study of the drawings, thedisclosure, and the appended claims.

The following Examples are provided to further elucidate various aspectsof the present teachings and is not provided to indicate necessarilyoptimal ways of practicing the invention or optimal results that may beobtained.

EXAMPLES Example 1

FIGS. 6A, 6B and 6C schematically depicts a conventional standardlaryngoscope 10 this is used primarily for vocal cord microsurgery. Somesurgeons prefer this laryngoscope because of the flare at the distal endof the speculum. The laryngoscope 10 includes a speculum 12 that extendsfrom a proximal end (PE) to a distal end (DE). The laryngoscope 10includes a handle attachment element 13 that allows coupling thespeculum to a vertical handle for manipulating the speculum, e.g., forpositioning the speculum in a patient's aerodigestive tract. Thespeculum 12 provides a lumen 14 for providing visual access to asurgical site. The speculum 12, however, suffers from a number ofshortcomings. For example, the introduction of light into the lumen 14would require clipping a light source in the lumen or introducing thelight laterally into the lumen. These options can, however, result in atleast partial obstruction of the lumen and/or inefficient illuminationof the target site. Further, increasing the inner diameter of the lumencan result in a laryngoscope that is difficult to position within apatient's aerodigestive tract.

FIGS. 7A and 7B present structural finite element analysis offorces/pressures to which such a laryngoscope can be subjected in use,demonstrating instability and deformation that can occur with forcesassociated with a suspension gallows.

Example 2

FIGS. 8A, 8B, 8C, 8D, and 8E show a slim Universal Glottiscope speculum1000 according to an embodiment of the present teachings (the handle towhich the speculum can be attached is not shown). More specifically,FIG. 8A is a side view of the speculum depicting a top plate 1012 thatis coupled to a base plate 1010. FIG. 8B (proximal view) shows a cutawayview of removable light and suction cannulas 1016/1018 that arepositioned in channels in the base plate. FIG. 8C (distal view angledup) shows widened distal end of the speculum from the centralized aspectwhere the speculum narrows to accommodate the glossotonsillar sulcus andposterior floor-of-mouth. FIG. 8D (distal view angled down) shows theinside of the distal speculum where the suction and light cannulas aresituated along the inner floor of the base plate. FIG. 8E (distal viewangled down more) shows the removable suction and light cannulasretracted to better demonstrate the inside depth of the distal baseplate. The angled distal views can be fully utilized by titling asurgical microscope used to view a surgical site using the speculum.

The speculum 1000 can be fabricated using, a suitable metal, e.g., acobolt-chromium alloy and employing 3-D printing fabrication techniques.

The speculum 1000 extends from a proximal end (PE) to a distal end (DE).The base plate 1010 (herein also referred to as the bottom plate or thebottom portion) that can be removably engaged with the top plate 1012 ofthe speculum so as to provide a lumen 1014 through which visual accessto a target site, e.g., a patient's larynx, can be achieved. As notedabove, the two cannulas 1016/1018 can be coupled to the speculum, whereone of the cannulas is used for providing suction and the other is usedfor introducing an optical fiber into the speculum for illuminating thetarget site.

Various features of the base plate and the top plate of the speculumhave been designed to maximize visual access to a target site whileensuring that the speculum can withstand forces applied thereto duringuse.

For example, with reference to FIGS. 9A and 9B, the base plate 1010slides into the top plate (herein also referred to as the upper aspect)of the speculum and includes a curved bottom surface 1010 a (alsoreferred to as the bottom wall), rather than a flat bottom surface toincrease the inner diameter of the lumen 1014, thereby providingenhanced visual access to the target site. In some embodiments, thecurved bottom surface of the base plate can be characterized by aplurality of radii of curvature. In some embodiments, the curved bottomsurface of the base plate can be U-shaped, e.g., with short lateralvertical limbs and an arch that extends between the vertical limbs.

The base plate 1010 includes a proximal portion 1010 b that is titledrelative to the rest of the base plate, where the tilt is depicted by anangle φ. The tilt of the proximal portion of the base plate relative tothe rest of the base plate can facilitate the introduction of twocannulas 1016/1018 without the obstruction of the laryngoscope's lumen.

With continued reference to FIGS. 9A and 9B, in this embodiment theproximal portion of the base plate 1010 includes two depressions 1010 d/1010 e (herein also referred to as cut-out portions), which have beenformed by removing material forming the base plate. The depressions 1010d/ 1010 e can increase the exposure of a surgical field in the posteriorglottis and interarytenoid region.

With particular reference to FIGS. 8A as well as 9A and 9B, a cover 1011coupled to the base plate includes two channels 1011 a/ 1011 b throughwhich the cannulas 1016/1018 can extend. The cover 1011 helps retain thecannulas within the speculum. In this example, the length (L) of thecover has been selected to be as small as possible to minimize anyobstruction that the cover may present with respect to a surgeon'svisual access to the target site while ensuring that cannulas areretained within the speculum. In this embodiment, the cover 1011includes a cut-out 1011 f that further enhances the visual access to thetarget site.

Further, the cannulas are removably positioned within the lumen of thespeculum and hence can be removed, if desired, e.g., prior tocommencement of a surgical procedure, to enhance the field of viewprovided by the speculum to the surgeon.

With particular reference to FIG. 8A, the top plate 1012 of the speculumincludes a curved top wall 1012 a, where the top wall extends to twoopposed side ledge portions 1012 b that allow removable engagement ofthe top plate of the speculum with the base plate. The proximal end ofthe top plate 1012 includes a notch 1012 c that further enhances thefield of view that the speculum can provide to a surgeon.

With particular reference to FIG. 8A, upon coupling of the base platewith the top plate to form the speculum, two opposed lateral slots (oneof which 1022 a is visible in the figure) are formed at a proximalportion of the speculum, which can facilitate viewing of the targetsite. In this embodiment, each lateral slot has a length (L), which canbe defined as the distance between the most proximal end of the topplate and the entrance of the lumen 1014 (i.e., the proximal end of thelumen) and a maximum width (W), which is herein also referred to as themaximum height, i.e., the maximum vertical separation between the topplate and the bottom plate. The length and the width of the lateralslots are maximized while ensuring that the speculum retains sufficientstructural integrity, e.g., via enforcement of certain portions thereof,to maximize the field-of-view presented to the surgeon and ensure thatthe speculum can withstand forces applied thereto during use. Ingeneral, the length and the height of the slots can be selected, e.g.,based on an intended patient population and can vary, for example, basedon age and gender. By way of example, and without limitation, in someembodiments the length of the slots can be in a range of about 5 mm toabout 7 cm, e.g., 1 cm to about 5 cm, and the maximum height of theslots can be in a range of about 3 mm to about 2 cm, e.g., about 5 mm toabout 1 cm.

By way of example, structural finite element analysis can be employed toassess strain/stress pressures at various regions of the speculum, andin particular in a region in proximity of the junction between a handleattachment element 1022 and the top plate of the speculum. FIG. 9D showstheoretically-calculated maps of pressures experienced by variousportions of the proximal aspect of the speculum during its use by asurgeon. Such structural finite element analysis of the stress/strainpressures to which various segments of the speculum are subjected duringuse can inform the reinforcement of those sections, e.g., by increasingthe thickness of those sections and/or using a different material, e.g.,a different metal, for forming those segments.

By way of example, it was discovered that increasing the length of thelateral slots may cause structural weakening of the connection betweenthe handle attachment element and the top plate of the speculum. Withparticular reference to FIG. 9C, in order to address such potentialstructural weakening, additional material 1024 can be added to the topplate 1012 of the speculum in a region in proximity of the junctionbetween the handle attachment element and the top plate to structurallyreinforce this region by increasing its thickness, thereby providingadditional structural support for withstanding forces applied during useof the speculum. More specifically, in this embodiment, the speculuminclude thicker metal and contoured midline rib that is designed towithstand the extreme forces on the top plate adjacent to the proximalslots and the connector (herein referred to also as the handleattachment element) for coupling the speculum to a vertical handle (notshown). For example, the thickness of the material 1024 can vary fromabout X mm to about X mm.

With reference to FIGS. 10A, 10B, 10C, and 10D, in some embodiments, theadvantageous features of a transoral instrument according to the presentteachings can be integrated with standard features of conventionalinstruments to achieve an enhanced instrument, e.g., via redesign of astandard instrument in accordance with the present teachings. Forexample, a speculum 2000 combines the proximal slots 2002/2004 and abase plate 2006 as disclosed herein, such as those discussed above inconnection with the speculum 1000, with the distal portion of the topplate of a standard conventional speculum to form a hybrid speculum. Itis noted that a notch 2006 formed at the proximal end of the speculum'stop plate further enhances the visual access to a surgical site.

FIG. 10D shows a finite element analysis of pressures experienced by theproximal portion of the speculum 2000 when in use.

The use of 3-D fabrication techniques can be particularly advantageousin providing enhanced structural support in specific areas of the scope,such as the added material discussed above. In particular, 3-Dfabrication techniques allow precise and cost effective ways offabricating different portions of a speculum with different shapesand/or sizes and/or compositions. For example, in this example, thestructural reinforcement of the speculum in a region in vicinity of thejunction between the top plate and the handle attachment element wasachieved by adding additional material to that region to increase itsthickness. In other embodiments, such structural reinforcement ofcertain segments of the speculum can be achieved, for example, by usinga different material for forming those segments, e.g., using a differentmetal.

Further, as shown schematically in FIGS. 11A and 11B, a transoralinstrument according to the present teachings allows a microscope thatis optically coupled to the instrument for viewing a surgical site to betilted, e.g., up to about 30 degrees relative to the longitudinal axisof the instrument, to allow the surgeon a better visual access to thesurgical site.

In the claims, the word “comprising” does not exclude other elements orsteps, and the indefinite article “a” or “an” does not exclude aplurality. A single processor or other processing unit may fulfill thefunctions of several items recited in the claims. The mere fact thatcertain measures are recited in mutually different dependent claims doesnot indicate that a combination of these measured cannot be used toadvantage. Any reference signs in the claims should not be construed aslimiting the scope.

Those having ordinary skill in the art will appreciate that variouschanges can be made to the above embodiments without departing from thescope of the present teachings.

What is claimed is:
 1. A method of redesigning a laryngoscope, apharyngoscope, or an oral cavity retractor, comprising: generating acomputerized 3-D model of a laryngoscope, pharyngoscope, or an oralcavity retractor, adjusting one or more parameters of the 3-D model toobtain a 3-D design of a laryngoscope, pharyngoscope, or oral cavityretractor that can provide a desired visual access to the upperaerodigestive tract of a patient or a group of patients, fabricating alaryngoscope, pharyngoscope, or an oral cavity retractor based on said3-D design using an additive manufacturing technique.
 2. The method ofclaim 1, wherein said additive manufacturing technique comprises 3-Dprinting.
 3. The method of claim 1, further comprising acquiringanatomical profile of a patient or a group of patients and generatingsaid computerized 3-D model based on said anatomical profile.
 4. Themethod of claim 1, further comprising utilizing a structural finiteelement analysis to identify one or more segments or componentsassociated with said 3-D design that require structural reinforcement.5. The method of claim 5, wherein said fabricating step thelaryngoscope, the pharyngoscope of the oral cavity retractor comprisesstructurally configuring said identified one or more segments orcomponents so as to provide structural reinforcement of said segments orcomponents.
 6. The method of claim 6, wherein the step of structurallyconfiguring said identified one or more segments or components comprisesselecting any of a thickness, shape and composition of said segments orcomponents such that said segments or components can withstand forcesapplied thereto during use of said laryngoscope, pharyngoscope, and theoral cavity retractor.
 7. The method of claim 1, wherein saidlaryngoscope comprises a speculum having a top plate coupled to a baseplate and said method includes adjusting a thickness, shape, andcomposition of at least a portion of said top plate.
 8. The method ofclaim 1, wherein said desired visual access is characterized by amaximum tilt of a surgical microscope optically coupled to any of saidlaryngoscope, pharyngoscope and the oral cavity retractor relative to alongitudinal axis of any of said laryngoscope, pharyngoscope and theoral cavity retractor that can be used for viewing a surgical site ofinterest in the aerodigestive tract of a patient or a group of patients.9. The method of claim 8, wherein said maximum tilt is about 30 degrees.10. The method of claim 8, wherein said surgical site of interestcomprises an anatomical structure of the upper aerodigestive tract. 11.A method comprising: generating an anatomical profile of the upperaerodigestive tract associated with a patient or a group of patients;and producing at least one component of a laryngoscope, pharyngoscope,or oral cavity retractor based on the anatomical profile.
 12. The methodof claim 11, wherein the step of generating the anatomical profilecomprises utilizing image data of the aerodigestive tract.
 13. Themethod of claim 11, wherein the anatomical profile includes thethree-dimensional profile of jaw-opening capacity, aerodigestive lumen,and anatomical soft-tissue structural conformation as well as arheological assessment of the anatomic soft tissues peripheral to theairway lumen.
 14. The method of claim 11, further comprising: producingthe component of the laryngoscope, pharyngoscope, or oral cavityretractor with a three-dimensional (3D) printer.
 15. The method of claim14, wherein the component comprises a metal, plastic, or compositematerial.
 16. The method of claim 11, further comprising: determining amaterial of the component of the laryngoscope based on at least one ofthe anatomical profiles, structural requirements, ease of maintenanceand sterilization, and economy of production.
 17. The method of claim11, wherein the component is a top plate of a speculum.
 18. The methodof claim 11, wherein the component is a baseplate of a speculum.
 19. Themethod of claim 11 , further comprising: determining a parameter of thecomponent based on the anatomical profile, and producing the componentbased on the determined parameter.
 20. The method of claim 19, whereinthe parameter includes the length of any of the speculum and/or the baseplate, the inner diameter of the lumen of the laryngoscope, the radiusof curvature of the speculum, a tilt angle of a proximal portion of thebase plate relative to the rest of the baseplate.
 21. A systemcomprising: a component producing system; a computer-readable storagemedium with computer readable program instructions; and a processor incommunication with the computer-readable storage medium, wherein theprocessor is configured to execute computer readable programinstructions stored in the computer-readable storage medium which causesthe processor to: determine an anatomical profile of a patient; and senda signal to produce the component to a component producing system basedon the anatomical profile, wherein in response to receiving the signal,the component-producing system is configured to produce the componentbased on the anatomical profile.
 22. The system of claim 21, wherein theprocessor is further configured to determine parameters of a componentof a laryngoscope based on the anatomical profile and in response toreceiving the signal, and the component producing system is furtherconfigured to produce the component based on the parameters.
 23. Thesystem of claim 22, wherein the parameters include the length of any ofthe speculum and/or the base plate, the inner diameter of the lumen ofthe laryngoscope, the radius of curvature of the speculum, a tilt angleof a proximal portion of the base plate relative to the rest of thebaseplate.
 24. The system of claim 22, wherein the configured processoris further configured to determine the parameter based on image data.25. The system of claim 21, wherein the component producing system is a3D printer or other additive manufacturing equipment.
 26. The system ofclaim 21, wherein the component is a speculum.
 27. The system of claim21, wherein the component is a baseplate.
 28. The system of claim 21,wherein the material of the component is metal, plastic, or a composite.29. The system of claim 21, wherein the configured processor is furtherconfigured to: determine the material based on the anatomical profile.30. A method of fabricating a laryngoscope, pharyngoscope, ororal-cavity retractor having a speculum releasably attached to abaseplate for use with an individual patient, comprising: obtaininganatomical data regarding an individual patient's larynx, obtaining oneor more structural and/or compositional parameters of at least one ofthe speculum and the baseplate by adjusting the parameters so as toobtain a desired visual access to a site of interest when using thespeculum to visualize that site in the patient, and using the parametersto fabricate the speculum and the baseplate.